Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation; Availability, 50372-50373 [2012-20383]
Download as PDF
<![CDATA[
50372
Federal Register / Vol. 77, No. 162 / Tuesday, August 21, 2012 / Rules and Regulations
1. Is not a ‘‘significant regulatory
action’’ under Executive Order 12866;
2. Is not a ‘‘significant rule’’ under the
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in
Alaska; and
4. Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
We prepared a regulatory evaluation
of the estimated costs to comply with
this AD and placed it in the AD docket.
Examining the AD Docket
You may examine the AD docket on
the Internet at https://
www.regulations.gov; or in person at the
Docket Operations office between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket
contains the NPRM (77 FR 20746, April
6, 2012), the regulatory evaluation, any
comments received, and other
information. The street address for the
Docket Operations office (telephone
(800) 647–5527) is in the ADDRESSES
section. Comments will be available in
the AD docket shortly after receipt.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
Adoption of the Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new AD:
■
2012–16–15 Bombardier, Inc.: Amendment
39–17162. Docket No. FAA–2012–0328;
Directorate Identifier 2011–NM–259–AD.
pmangrum on DSK3VPTVN1PROD with RULES
(a) Effective Date
This airworthiness directive (AD) becomes
effective September 25, 2012.
(b) Affected ADs
None.
(c) Applicability
This AD applies to Bombardier, Inc. Model
CL–600–2B19 (Regional Jet Series 100 & 440)
airplanes, certificated in any category; serial
numbers 7003 through 7067 inclusive, 7069
through 7990 inclusive, and 8000 through
8112 inclusive.
VerDate Mar<15>2010
15:03 Aug 20, 2012
Jkt 226001
(d) Subject
Air Transport Association (ATA) of
America Code 71: Powerplant.
(e) Reason
This AD was prompted by reports of
jamming/malfunctioning of the left-hand
engine thrust control mechanism. We are
issuing this AD to prevent jamming/
malfunctioning of the left-hand engine thrust
control mechanism, which could lead to loss
of control of the airplane.
(f) Compliance
You are responsible for having the actions
required by this AD performed within the
compliance times specified, unless the
actions have already been done.
(g) Actions
Within 36 months or 6,000 flight hours
after the effective date of this AD, whichever
occurs first: Modify the left-hand engine
upper core-cowl, in accordance with the
Accomplishment Instructions of Bombardier
Service Bulletin 601R–71–033, dated August
24, 2011.
(h) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, New York Aircraft
Certification Office (ACO), ANE–170, FAA,
has the authority to approve AMOCs for this
AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal
inspector or local Flight Standards District
Office, as appropriate. If sending information
directly to the New York ACO, send it to
ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO,
1600 Stewart Avenue, Suite 410, Westbury,
New York 11590; telephone 516–228–7300;
fax 516–794–5531. Before using any
approved AMOC, notify your appropriate
principal inspector, or lacking a principal
inspector, the manager of the local flight
standards district office/certificate holding
district office. The AMOC approval letter
must specifically reference this AD.
(2) Airworthy Product: For any requirement
in this AD to obtain corrective actions from
a manufacturer or other source, use these
actions if they are FAA-approved. Corrective
actions are considered FAA-approved if they
are approved by the State of Design Authority
(or their delegated agent). You are required
to assure the product is airworthy before it
is returned to service.
(i) Related Information
Refer to MCAI Canadian Airworthiness
Directive CF–2011–38, dated October 19,
2011; and Bombardier Service Bulletin 601R–
71–033, dated August 24, 2011; for related
information.
(j) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
PO 00000
Frm 00002
Fmt 4700
Sfmt 4700
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
(i) Bombardier Service Bulletin 601R–71–
033, dated August 24, 2011.
(ii) Reserved.
(3) For Bombardier service information
identified in this AD, contact Bombardier,
ˆ
Inc., 400 Cote-Vertu Road West, Dorval,
´
Quebec H4S 1Y9, Canada; telephone 514–
855–5000; fax 514–855–7401; email
thd.crj@aero.bombardier.com; Internet https://
www.bombardier.com.
(4) You may review copies of the service
information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of
this material at the FAA, call 425–227–1221.
(5) You may also review copies of the
service information that is incorporated by
reference at the National Archives and
Records Administration (NARA). For
information on the availability of this
material at an NARA facility, call 202–741–
6030, or go to https://www.archives.gov/
federal_register/code_of_federal_regulations/
ibr_locations.html.
Issued in Renton, Washington, on August
9, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 2012–20172 Filed 8–20–12; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16 and 118
[Docket No. FDA–2011–D–0398]
Guidance for Industry: Questions and
Answers Regarding the Final Rule,
Prevention of Salmonella Enteritidis in
Shell Eggs During Production,
Storage, and Transportation;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance entitled ‘‘Guidance for
Industry: Questions and Answers
Regarding the Final Rule, Prevention of
Salmonella Enteritidis in Shell Eggs
During Production, Storage, and
Transportation.’’ The guidance contains
questions we have received on the final
rule since its publication and responses
to those questions, and is intended to
assist egg producers and other persons
who are covered by the final rule.
SUMMARY:
E:\FR\FM\21AUR1.SGM
21AUR1
Federal Register / Vol. 77, No. 162 / Tuesday, August 21, 2012 / Rules and Regulations
Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Plant and Dairy Food Safety/
Office of Food Safety, Center for Food
Safety and Applied Nutrition (HFS–
315), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740. Send one self-addressed
adhesive label to assist that office in
processing your requests. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Nancy Bufano, Center for Food Safety
and Applied Nutrition (HFS–316), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–1493.
SUPPLEMENTARY INFORMATION:
pmangrum on DSK3VPTVN1PROD with RULES
DATES:
I. Background
In the Federal Register of July 9, 2009
(74 FR 33030), we issued a final rule
requiring shell egg producers to
implement measures to prevent
Salmonella Enteritidis (SE) from
contaminating eggs on the farm and
from further growth during storage and
transportation, and requiring these
producers to maintain records
concerning their compliance with the
final rule and to register with FDA. This
final rule became effective September 8,
2009. In the Federal Register of July 13,
2011 (76 FR 41157), we made available
a draft guidance entitled ‘‘Questions and
Answers Regarding the Final Rule,
Prevention of Salmonella Enteritidis in
Shell Eggs During Production, Storage,
and Transportation’’ and gave interested
parties an opportunity to submit
comments by September 12, 2011. We
have reviewed and evaluated these
comments and have modified the
guidance where appropriate.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents our current
thinking on how to interpret the
requirements in the final rule, including
questions and answers on compliance
dates; coverage; definitions; SE
prevention measures; sampling and
testing for SE; registration; and
compliance and enforcement. It does
not create or confer any rights for or on
any person and does not operate to bind
VerDate Mar<15>2010
15:03 Aug 20, 2012
Jkt 226001
FDA or the public. An alternate
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 118.5, 118.6, 118.10, and 118.11
have been approved under OMB control
number 0910–0660.
50373
45480), relating to the use of business
aircraft for entertainment.
DATES: Effective Date: This correction is
effective on August 21, 2012 and is
applicable on August 1, 2012.
FOR FURTHER INFORMATION CONTACT:
Michael Nixon (section 274), (202) 622–
4930; or Lynne A. Camillo (section 61),
(202) 622–6040 (not toll-free numbers).
SUPPLEMENTARY INFORMATION:
Background
The final regulation (TD 9597) that is
the subject of this correction is under
section 274 of the Internal Revenue
Code.
III. Comments
Interested persons may submit written
comments regarding this document to
the Division of Dockets Management
(see ADDRESSES) or electronic comments
to https://www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Need for Correction
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://
www.fda.gov/FoodGuidances or https://
www.regulations.gov. Always access an
FDA document using the FDA Web site
listed previously to find the most
current version of the guidance.
LaNita Van Dyke,
Chief, Legal Processing Division, Associate
Chief Counsel, Procedure and
Administration.
Dated: August 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20383 Filed 8–20–12; 8:45 am]
BILLING CODE 4160–01–P
As published, TD 9597 contains an
error that may prove to be misleading
and is in need of clarification.
Correction of Publication
Accordingly, the publication of the
final regulation (TD 9597) that was the
subject of FR Doc. 2012–18693, is
corrected as follows:
On page 45480, column 1, under the
caption DATES: line five, the language
‘‘1.274–9(e), and 1.274–10(h)’’ is
corrected to read ‘‘1.274–9(e), and
1.274–10(g)’’.
[FR Doc. 2012–20436 Filed 8–20–12; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Parts 100 and 165
[Docket No. USCG–2011–0551]
DEPARTMENT OF THE TREASURY
RIN 1625–AA00; 1625–AA08
Internal Revenue Service
Special Local Regulation and Safety
Zone; America’s Cup World Series
Regattas, San Francisco Bay; San
Francisco, CA
26 CFR Part 1
[TD 9597]
ACTION:
Deductions for Entertainment Use of
Business Aircraft; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correction to final regulations.
AGENCY:
This document corrects the
final regulation (TD 9597) that was
published in the Federal Register on
Wednesday, August 1, 2012, (77 FR
SUMMARY:
PO 00000
Frm 00003
Fmt 4700
Coast Guard, DHS.
Temporary final rule.
AGENCY:
RIN–1545–BF34
Sfmt 4700
The Coast Guard has
established a special local regulation
and a safety zone for sailing events
scheduled to occur on the waters of San
Francisco Bay adjacent to the City of
San Francisco waterfront in the vicinity
of the Golden Gate Bridge and Alcatraz
Island. This rule will revise the start
time for enforcement on August 26,
2012, to 11:30 a.m. instead of noon. This
SUMMARY:
E:\FR\FM\21AUR1.SGM
21AUR1
]]>Agencies
[Federal Register Volume 77, Number 162 (Tuesday, August 21, 2012)]
[Rules and Regulations]
[Pages 50372-50373]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20383]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16 and 118
[Docket No. FDA-2011-D-0398]
Guidance for Industry: Questions and Answers Regarding the Final
Rule, Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance entitled ``Guidance for Industry: Questions
and Answers Regarding the Final Rule, Prevention of Salmonella
Enteritidis in Shell Eggs During Production, Storage, and
Transportation.'' The guidance contains questions we have received on
the final rule since its publication and responses to those questions,
and is intended to assist egg producers and other persons who are
covered by the final rule.
[[Page 50373]]
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Plant and Dairy Food Safety/Office of Food Safety,
Center for Food Safety and Applied Nutrition (HFS-315), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Nancy Bufano, Center for Food Safety
and Applied Nutrition (HFS-316), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-1493.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 9, 2009 (74 FR 33030), we issued a
final rule requiring shell egg producers to implement measures to
prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm
and from further growth during storage and transportation, and
requiring these producers to maintain records concerning their
compliance with the final rule and to register with FDA. This final
rule became effective September 8, 2009. In the Federal Register of
July 13, 2011 (76 FR 41157), we made available a draft guidance
entitled ``Questions and Answers Regarding the Final Rule, Prevention
of Salmonella Enteritidis in Shell Eggs During Production, Storage, and
Transportation'' and gave interested parties an opportunity to submit
comments by September 12, 2011. We have reviewed and evaluated these
comments and have modified the guidance where appropriate.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents our
current thinking on how to interpret the requirements in the final
rule, including questions and answers on compliance dates; coverage;
definitions; SE prevention measures; sampling and testing for SE;
registration; and compliance and enforcement. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternate approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 118.5, 118.6, 118.10, and 118.11
have been approved under OMB control number 0910-0660.
III. Comments
Interested persons may submit written comments regarding this
document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to https://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Always
access an FDA document using the FDA Web site listed previously to find
the most current version of the guidance.
Dated: August 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20383 Filed 8-20-12; 8:45 am]
BILLING CODE 4160-01-P
